The Impact of Nebivolol Versus Metoprolol on Quality of Life
In an open label analysis, nebivolol has been shown to have a positive impact on quality of life in the general hypertensive population. That is, patients treated with nebivolol reported less side effects compared to those treated with metoprolol. Also, more nebivolol treated patients reached normalization of blood pressure. Although there is no data, it is believed that the impact would be similar in renal transplant recipients.
The primary goal of this study is to determine if nebivolol will improve the quality of life measurements of kidney transplant recipients as compared to those treated with metoprolol succinate. This will be measured by comparing the scores of four quality of life questionnaires taken before and after 12 weeks of treatment with study drug. Other aims of this study are to determine if the use of nebivolol is cost-effective in the renal transplant recipient; determine if there is a change in urine protein excretion and renal function with the use of nebivolol; and determine the number of patients that maintain or achieve a target blood pressure of ≤ 120/80 mmHg.
Transplant; Failure, Kidney
Drug: Metoprolol succinate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The Impact of Nebivolol Versus Metoprolol on Quality of Life Measures and Cost-effectiveness in Stable Renal Transplant Recipients|
- Quality of Life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Primary outcome measure will be the change from the Screening/Enrollment Visit to the End of the Study/Early Termination visit in scores of four quality of life questionnaires.
- Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluate the number of subjects in the nebivolol group that are at goal blood pressure (120/80 mmHg) as compared to those in the metoprolol succinate group.
- Cost-effectiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluate the cost-effectiveness of nebivolol as compared to metoprolol succinate.
- Urine Protein and calculated GFR [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Evaluate change in urinary protein excretion and calculated glomerular filtration rate in subjects in the nebivolol group as compared with those in the metoprolol succinate group.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Nebivolol||
Subject will take nebivolol daily for 12 weeks.
Other Name: Bystolic
|Active Comparator: Metoprolol Succinate||
Drug: Metoprolol succinate
Subject will take metoprolol succinate daily for 12 weeks.
Other Name: Toprol XL
|Contact: Steven Gabardi, PharmD, FCCP, BCPSemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Sub-Investigator: Anil Chandraker, MD|
|Sub-Investigator: Reza Abdi, MD|
|Sub-Investigator: Nader Najafian, MD|
|Sub-Investigator: Edgar Milford, MD|
|Sub-Investigator: Jamil Azzi, MD|
|Sub-Investigator: Leonardo Riella, MD, PhD|
|Burlington, Massachusetts, United States, 01805|
|Contact: Monica Grafals, MD 781-744-2500 Monica.Grafals@Lahey.org|
|Principal Investigator:||Steven Gabardi, PharmD, FCCP, BCPS||Transplant Surgery|